AU2024257424A1

AU2024257424A1 - Aesthetic treatment systems and methods

Info

Publication number: AU2024257424A1
Application number: AU2024257424A
Authority: AU
Inventors: Arthur Ferdinand; Alejandro GARCIA-RUBIO; Alicia HOLLER; Sami LAMA; Martin Leugers; Jamie PARK; Jonathan Podmore; Sam RHEA SARCIA; Evan VANDERBRINK; Tricia Wright
Original assignee: Revelle Aesthetics Inc
Current assignee: Revelle Aesthetics Inc
Priority date: 2023-04-20
Filing date: 2024-04-18
Publication date: 2025-11-27
Also published as: CO2025015912A2; WO2024220637A3; WO2024220637A2; MX2025012430A; CN121263141A

Abstract

Systems and methods for aesthetic treatment of skin including an apparatus that applies or a method involving separating tissue to eliminate or reduce the appearance of unwanted features. In one approach, an interventional tool is placed between tissue layers to engage and treat connecting tissue layers.

Description

AESTHETIC TREATMENT SYSTEMS AND METHODS

FIELD OF THE DISCLOSURE

[001] The present disclosure generally relates to aesthetic treatment systems and methods.

BACKGROUND OF THE DISCLOSURE

[002] There is a continuing need for an effective approach to improving the appearance of the surface of skin. In one or more approaches, it is desirable to treat cellulite, also known as gynoid lipodystrophy, nodular liposclerosis, edematofibrosclerotic panniculopathy, panniculosis, adiposis edematosa, demopanniculosis deformans or status protrusus cutis. Additionally, there is a need for treatment devices for use in scar release (e.g., release of tethered scars, contractures (e.g., bum scar), subdermal fibrosis, or adhesions) in trunk, buttocks, or extremities, acne subcision, facial fold and/or facial lift procedures. Moreover, there is a need for proactive treatment modalities that prevent future or recurrence of skin discontinuities and which are easy and effective to use.

[003] It has been reported that more than 85% of women have cellulite thus suggesting that cellulite is a physiologic rather than pathologic condition. The existence of fat in the reticular dermis alone is not thought to cause cellulite. Cellulite can be described as the herniation of subcutaneous fat within fibrous connective tissue that is expressed as dimpling of the skin. This fat loading can lead to stress on connective tissue located between fat lobules. Such dimpling is more common in women than men due to the orientation of subcutaneous fibrous structures defining chambers containing fat cells. In fact, it is this structure that is believed to cause the appearance of cellulite more than being overweight. Often, cellulite appears on the pelvic region including the buttocks, lower limbs and abdomen.

[004] Subdermal fat layers below the epidermis are contained between dermal layers connected by septa which act as connective tissue between the dermal layers. In men, the septa are arranged more randomly and densely oriented in a more criss-crossed configuration while the septa in women are generally more parallel in arrangement. Also, men have thicker dermis and more angled septa relative to the skin surface whereas women have relatively thinner dermis which thins with age, and septa that are perpendicular to the skin surface. Moreover, women with cellulite have exhibited thickening of the septa in the regions of cellulite and tensioning of septa highlights cellulite. In women, fat storage in adipose tissue has a biological purpose in that it is maximized ensuring adequate caloric availability for pregnancy and lactation. An increase in fluid retention or proliferation of adipose tissue in such subdermal fat layers can further result in the appearance of cellulite where the septa are maintaining a first distance between dermal layers, thus creating dimples, wherein pockets between septa bulges. Over time, the septa may stretch, then eventually contract and harden thus retaining tissue layers at fixed distances, but pockets between such septa may be expanded thus adding to the appearance of cellulite.

[005] Various approaches have been taken to treat or address cellulite. Early treatments involved attempts at increasing circulation and fat oxidation in areas exhibiting cellulite. Here, substances such as hyaluronic acid and aminophylline were injected in the target areas to reduce cellulite. Other approaches involved electroporating the target areas followed by the application of mesotherapy, or applying dermological creams or other supplements to cellulite. These approaches could be supplemented by massage or massage was used alone for the purpose of promoting increased fat reabsorption or drainage of fluids and toxins in the treated areas. Ultrasound has also been proposed to disrupt subcutaneous tissues and fat and has been used in combination with liposuction. Low acoustic pressure in combination with the infiltration of microbubbles has also been employed to reduce the appearance of cellulite, as has the use of other energies such as lasers and radio frequency. Such approaches have been characterized by limited or unpredictable results. More recently, the cutting of septa with blades or needles in the subdermal region has been employed. Prior approaches have been found to be labor intensive and very traumatic to the tissue leading to numerous skin entry sites, bleeding, bruising, tough tissue nodules, long, painful recoveries and inconsistent results.

[006] There is also a significant need for devices to treat scars (e.g., release of tethered scars, contractures (e.g., burn scar), subdermal fibrosis, or adhesions) in trunk, buttocks, or extremities, and acne, or for use in facial fold and/or facial lift procedures. In conventionally available procedures, treatment devices are required to be inserted within tissue close to the interventional site, and travel within tissue to the site results in cutting or disrupting non-target tissue. There is thus a need for a treatment device that can be placed into tissue at more cosmetically desirable locations where the treatment device includes a blade that is only exposed once it reaches the treatment tissue. In addition, there are benefits associated with using a single entry site to treat multiple target locations through the single entry site since safe and minimally traumatic navigation between entry and the targeted tissue is desirable.

[007J Accordingly, there is a need for effective and efficient approaches to improving the aesthetic appearance of skin including treating, minimizing or eliminating trauma. These approaches should be associated with predictable results and be relatively easy to employ.

[008] The present disclosure addresses these and other needs.

SUMMARY OF THE DISCLOSURE

[009] Briefly and in general terms, the present disclosure is directed towards aesthetic treatment systems and methods involving an apparatus that facilitates and methods involving, depending on the system used and force applied by the user, stretching, re-orienting, disrupting, cutting, slicing, and/or tearing tissue. In one aspect, the treatment approach involves a tissue cutting or slicing system. In another aspect, tissue cutting or slicing is combined with disruption and/or localized removal of fat.

[0010] In one embodiment, a cellulite treatment device is mounted at a distal end portion of a shaft and is sized and shaped to be advanced between tissue layers. In one particular aspect, fibrous septa that connect superior and inferior fascia plateaus within skin can be crossed or penetrated with the treatment device using one or more of an array of tools to engage, and depending on the tool used and force applied by the user, stretch, re-orient, tear, disrupt, cut or slice septa. By doing so, the target subcutaneous connective tissue associated with the surface defect can be directly modified with minimal impact to surrounding blood vessels and lymphatic system and fat can be more evenly distributed and skin can assume a smoother appearance.

[0011] In various aspects, a handle assembly is provided to actuate a treatment device. In one or more approaches, the handle assembly includes an actuatable assembly that controls configuring a treatment device into one or more of home or sheath, open or hook, and active or cut configurations. The actuatable assembly can include one or more of a slider, an active or cut button and a return home button. Alternatively, the handle assembly includes structure that facilitates an automatic return to home upon completion of stretching, re-orienting, tearing, disrupting, cutting or slicing of septa or other tissues. In an alternative approach, the handle assembly can embody a rocker assembly configured to minimize linear translation movement of an operator’s hand.

[0012] In one or more aspects, a cellulite treatment system embodies a tool facilitating an ability to reach and treat all target cellulite appearance areas through a single skin entry on each side of the patient or a limited number of entries through the skin. In certain aspects, such tool is sized, shaped and configured (e.g. less than or equal to about three millimeters diameter, more preferably less than or equal to about 2 millimeters, and blunt dissection tip) to be placed within and advanced between tissue layers on its own and without assistance from external skin stabilizing structure, such as a suction device. Entry points through the skin such as high on the hip under where a bikini or underwear strap would be and along creases or transitions between buttocks and thighs (for example, gluteal crease) are employed. Identification and assessment of target septa is accomplished by pushing, pulling or otherwise tensioning septa in areas believed to be associated with the appearance of cellulite on the outside of skin. It has been recognized by the inventors that septa causing a dimple or depression are located at various angles and locations relative to the dimple or depression observed on the skin and are not necessarily directly below such appearances of cellulite, and the treatment system and method is configured to identify the septa responsible for the appearance of cellulite that has been marked on the skin and target treatment on those septa and leave adjacent septa, blood vessels, etc. intact. Moreover, a range or grouping such as a small subset or a larger number of septa can be the structure causing a particular depression or dimple.

[0013] In one method, anesthetic is injected into the treatment site transcutaneously or subcutaneously, a cellulite treatment system is inserted subcutaneously across the treatment site and used to identify the septa responsible for a depression or dimple by pushing or pulling on various septa to cause a depression in the skin in the target area, and a cutting or slicing device or septa disruption structure is placed subcutaneously at the treatment site and employed to engage and cut or slice or break the septa tissue. In one particular aspect, the patient is directed to clench their buttocks and/or leg muscles to help facilitate identifying target areas and after septa treatment to confirm release of septa that create dimples or depressions. Alternatively, the physician can press in a cranial to caudal direction on the skin above the treatment target or pull from below the treatment target. Remote imaging or ultrasonic or fluoroscopic energy can be employed to observe the procedure. A resizing or alternative configuration of the treatment structure can be employed to complete the treatment of a particular area. The treatment device is then repositioned to treat additional areas. The treatment device can be configured to treat a plurality of areas simultaneously or in succession without having to be removed from the patient or a spot treatment approach can be taken. Additionally, through one or more entry points, various treatment trajectories are directed and in certain applications a steerable introducer is used to access treatment areas. Further, anti-inflammatory, collagenase, deoxycholic acid, salicylic acid, glycolic acid, hyaluronic acid, tranexamic acid or cellulite treatment medicants can be employed at the interventional site separately or directly by the interventional device or other procedural instrumentation. Aspects of the current invention include specific identification of the septa responsible for the cellulite appearance, severing or separation of those septa, confirmation intra-operatively that the separation of those septa was accomplished and the prevention of the re-appearance of the cellulite.

[0014] In various aspects, the treatment device can embody a mechanical connective tissue disrupting element and can include one or more of cutting structure that cooperates with a septa or connective tissue hooking or engaging element to hook or engage then, one or more cut, slice, tear or disrupt septa or connective tissue. One or more of the septa or connective tissue hooking element and the septa or connective tissue cutting element is convertible from a hooking configuration to a cutting configuration and from a cutting configuration to a hooking configuration or to a stored configuration. The treatment device can further include various approaches to blocking or shielding structure that selectively blocks or shields one or more cutting elements. In another particular approach, the treatment device is embodied in an elongate member insertable through the skin capable of expanding at least one region from a smaller state to a wider state, and when in the wider state is configurable to both hook and cut, slice or disrupt target septa or connective tissue. In one specific approach, a treatment device is embodied in an assembly including an elongate member that is configurable to present a hooked cutting structure for use in treating cellulite, scar (e.g., release of tethered scars, contractures (e.g., burn scar), subdermal fibrosis, or adhesions) in trunk, buttocks, or extremities, or connective tissue existing in tissue planes, and includes a damper that reduces noise and/or slows the return of the device to a home configuration. [0015] In various aspects, the treatment device can assume one or more of blades that are deployed and swing and have locked configurations, or can define disengageable scissor structure. In other aspects, the treatment device can further include electrodes configured to one or more of cut septa or treat other tissues at an interventional site. In other approaches, the treatment device can embody one or more of a self-cleaning electrode assembly or a scissor-tube cutting mechanism.

[0016] The cellulite treatment system also involves in certain approaches, illumination such as a bright light configured at or emitted through a tip of treatment structure or placed along or at strategic locations along treatment structure for the purposes of tracking advancement of the tool to the treatment site and locating intra-dermal structures at the treatment site. In this way, direct observation of the treatment device by transillumination through the skin is provided and positioning, depth and performance thereof subcutaneously is readily available to an operator.

[0017] In one or more further aspects, the disclosed devices can be used in scar release (e.g., release of tethered scars, contractures (e.g., burn scar), subdermal fibrosis, or adhesions) in trunk, buttocks, or extremities, acne subcision, facial fold and/or facial lift procedures, or in any area where tissue disruption is needed in the subcutaneous space between tissue layers of the body. Transillumination can be used or specific devices or systems can lack transillumination structures or assemblies. In various approaches, a treatment device can be placed into tissue at more cosmetically desirable locations where the treatment device includes a blade that is only exposed once it reaches the treatment tissue. In addition, a single entry site can be used to treat multiple target locations through the single entry site since safe and minimally traumatic navigation between entry and the targeted tissue is possible.

[0018] These and other features of the disclosure will become apparent to those persons skilled in the art upon reading the details of the systems and methods as more fully described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figs. 1A and B are perspective views, depicting cellulite on a subject’s skin and a plan for treating the cellulite.

[0020] Fig. 1C is a top view, depicting treatment of a subject lying on a treatment table.

[0021] Fig. ID is a top view, depicting a cellulite treatment assembly and approach for treating cellulite.

[0022] Fig. ID’ is a front view, depicting a scale device.

[0023] Figs. 1E-G are internal views, depicting the complex anatomy of septa.

[0024] Figs. 1H-1 are perspective and top views, depicting a depth calculation device.

[0025] Figs. 2A-G are partial cross-sectional views, depicting one embodiment of treating septa below a skin surface.

[0026] Figs. 3A-C are perspective, side and cross-sectional views, depicting one preferred embodiment of a treatment system.

[0027] Fig. 4A is a perspective view of a cellulite treatment assembly;

[0028] Fig. 4B is a right side view of the assembly of Fig. 4A;

[0029] Fig. 4C is a left side view of the assembly of Fig. 4A;

[0030] Fig. 4D is a rear side view of the assembly of Fig. 4A;

[0031] Fig. 4E is a front side view of the assembly of Fig. 4A;

[0032] Fig. 4F is a top side view of the assembly of Fig. 4A;

[0033] Fig. 4G is a bottom side view of the assembly of Fig. 4A;

[0034] Fig. 4H is a perspective view of another cellulite treatment assembly;

[0035] Fig. 41 is a right side view of the assembly of Fig. 4H;

[0036] Fig. 4J is a left side view of the assembly of Fig 4H;

[0037] Fig. 4K is a rear side view of the assembly of Fig. 4H;

[0038] Fig. 4L is a front side view of the assembly of Fig. 4H;

[0039] Fig. 4M is a top side view of the assembly of Fig. 4H;

[0040] Fig. 4N is a top side view of the assembly of Fig. 4H;

[0041] Figs. 4O-Q are cross-sectional and side views, depicting components of the handle assembly of Figs. 4A-H. [0042] Figs. 5A-D are partial cross-sectional and perspective views, depicting an alternative approach to a treatment device.

[0043] Figs. 6A-C are top views, depicting a treatment device including a disengageable scissor arrangement.

[0044] Figs. 7A-B are perspective views, depicting a treatment assembly including a deployable basket.

[0045] Figs. 8A-C are perspective views, depicting a further alternative approach to a treatment device.

[0046] Figs. 9A-I are top, side and perspective views, depicting yet further approaches to treatment devices.

[0047] Figs. 10A-D are partial cross-sectional side and perspective views, depicting another approach to a treatment system.

[0048] Figs. 11 A-B are top and end views, depicting a treatment assembly with an internal lumen.

[0049] Figs. 12A-B are side and perspective views, depicting additional features of a treatment assembly.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0050] Before the present systems and methods are described, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0051] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0052] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, the preferred methods and materials are now described.

[0053] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "the system" includes reference to one or more systems and equivalents thereof known to those skilled in the art, and so forth.

[0054] With reference to Figs. 1A-B, there is shown a person exhibiting cellulite 200 about their thighs and buttocks. In one approach to treatment, dimples, linear depression and/or other depressions characteristic of the cellulite 200 intended to be treated are identified or circled with a marker to mark or outline edges 204 of depressions, preferably while the patient is standing as for most patients the appearance of their cellulite disappears when they lie down on their stomach because gravity is pulling in a different direction. The patient can be asked to lunge or clench tissue to aid in the identification of treatment areas. Approximately an 8 mm margin area 205 around targeted dimples, linear depressions or other depressions is marked on a patient’s skin to identify an area for the physician to check for fibrous septa that are responsible for creating the dimple, liner depression or other depression. Such margins can assume various shapes dictated by the cellulite or depressions formed on a patient’s anatomy and for example, can be defined as circles, ellipses or D-shaped treatment margins and the margins can encompass one or more targeted areas. In another embodiment, computerized imaging equipment is used to locate and mark dimples and/or depressions. In Figs. 1A-B, dimples and depressions are marked for possible treatment. The physician treating the patient determines an instrument insertion site 210 and paths 212 that most efficiently treat cellulite with a minimal amount of insertion sites and instrument paths under the skin. Preferably, an instrument insertion site is chosen that is in a crease or fold of skin such as where the buttocks meet the thigh (i.e., gluteal crease) or in the crease between the two buttocks at a location that is not seen when the buttocks are in natural contact for improved cosmesis after the procedure healing period. In one embodiment, each depression can be divided into about 4 to 10 mm wide lanes, and preferably 6 mm wide lanes. In a preferred embodiment, with drawn 8 mm margins 205, each depression will thus have at least three lanes. Notably, multiple septa contribute to each depression. In certain patients, the inner thigh is chosen as an insertion site as this location is less visual as it heals, or the lateral thigh region or superior buttocks are used as alternative or additional insertion sites. Such treatment paths are selected by the operator preferably using a straight edge that bends or contours to the patient or can be generated automatically by employing a computerized controller programmed to most efficiently address and measure cellulite residing in a pre-defined treatment site. Each depression is treated from right to left, because in this particular embodiment the treatment device deploys to the left of the device and therefore treating from right to left makes it easier to keep track of which lanes have been treated. It is also within the scope of the invention to treat each depression from left to right or other patterns. In various approaches, a treatment plan can involve treating sites in one or more of a counter-clockwise, right to left, lateral to medial or proximal to distal order. Once all lanes have been treated, an entire depression is verified from right to left, for example, to confirm completed treatment of that depression, the treated depression can then be marked with a surgical marker as being treated after verification. The computerized controller can be associated with a scanner that identifies specific dimples and areas for treatment such as by employing laser technology. In this regard, the computerized controller includes a program specific to cellulite treatment and is used in conjunction with an electronic and mechanical device and comprises or includes a non-transitory computer-readable storage medium and a computer-program mechanism embedded therein to both identify treatment areas and to plot primary and alternative approaches to treatments. In another embodiment, computerized visualization and treatment planning equipment is used to assist the physician in determining insertion site locations and paths to be taken to the marked targets.

[0055] Once a treatment approach is planned, the patient lies down on their stomach on the treatment table. Alternatively, because of the minimally invasiveness of the current approach, a patient can be treated while standing, particularly for a small number of treatment targets, or while standing and leaning forward on a support and alternatively between standing and leaning forward so that gravity can help identify and confirm treatment of the targeted septa. The patient can also be asked to lunge or clench muscles to aid in identifying treatment sites. Moreover, the measurement device creates a complete three-dimensional map of all cellulite relative to normal skin. By dating and comparing improvement of volume of divots or dimples versus normal idealized surfaces, the operator calculates total and local volume benefits of therapy and track improvement over time.

[0056] In one specific approach, as shown in Fig. 1C, anesthesia (represented by the shaded area) is thoroughly delivered subcutaneously beyond marked areas (approximately 1.5 inches) so as to provide room for a distal end of the treatment device 225 within the anesthetized area (see Fig. ID). In this regard, a point-of-use IV bag can be used during treatment. During the course of administering anesthesia for a treatment procedure, physicians and their staff must track not only the total amount of anesthesia solution delivered, but may also wish to keep track of how much has been delivered to a particular area or region to be treated (e.g. - left or right buttock). It is important to understand total volume of anesthesia administered so as to avoid issues such as lidocaine toxicity, which can arise with higher volumes and/or concentrations of anesthetic. Typically, sites will prepare a single IV bag of anesthetic solution, and tracking how much is delivered to each region of the body can help assure the even distribution of anesthetic, so as not to run out prematurely, or deliver too little to an area.

[0057] To aid in tracking IV delivery and usage and to avoid inaccuracies, there can be provided a hanging scale 1204, with two independent displays (See Fig. ID’). Both displays can be configured to display mass or volume from a single sensor but may also be tared (“zeroed”) or reset independently of each other. This would allow the user to set one up to read total volume, and the other could be reset before anesthetic was delivered to each region. This would facilitate understanding regional delivery as well as total volume delivered. Such a scale could be configured to display mass in grams (ml of water) or ml of normal saline, which is very slightly different than water.

[0058] In one approach, multiple treatment targets along lines are treated from a single entry 210 at the lateral end of the gluteal crease (Fig. IB). Thus, treatment can be directed to treat targeted septa, or additionally or alternatively, treatment can be transverse, preferably perpendicular, to the linear depressions on the posterior thigh or lateral thigh as shown in Fig. 1C for illustrative purposes to treat targeted septa. Treatment can be directed at various positions about connecting tissue or septa. That is, septa can be engaged, stretched, re-oriented, torn, cut, sliced, ruptured or disrupted from various sides or angles respecting septa. Thus, septa can be treated from above, below or the sides of septa to achieve the best results. For example, in a particular situation, treatment can be most effective from above a particular connecting tissue to take advantage of gravity where treatment forces placed on the connecting tissue coincide with the direction of gravity or the direction that gravity most often works on a standing body, as it has been observed that cellulite is often most visible in a standing individual. Additionally, using a limited thigh line treatment, the entirety of underlying septa associated with a linear depression in skin are not disrupted or treated but rather treatment involves approaching the linear depression perpendicular to or at an angle thereto and just a portion of the underlying septa is released. The treatment instrument is re-sheathed and repositioned slightly such as a few millimeters thereby leaving an area of undisrupted or treated septa, followed by disrupting or treating additional septa and subsequent re-sheathing, repositioning and disrupting or treating further septa as deemed necessary.

[0059] Turning now to Fig. ID, there is shown a cellulite treatment assembly 220 and an elongate member or needle-sized structure preferably three millimeters or less, more preferably two millimeters or less, in diameter, like structure 224 extending longitudinally therefrom. A force gauge (electronic or mechanical) can be provided to ensure that a pre-determined amount of force would be applied to the tissue when testing the septa to prevent over or under pulling. A treatment device 225 capable of one or more of engaging, stretching, slicing, cutting or disrupting connective tissue is configured at a distal end portion of the elongate member 224 (e.g., Figs. 2A-G). A light source 352 is provided distal of the treatment device 225 to assist in guiding the treatment device 225 to targeted treatment locations. The treatment device can define an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical septa disrupting element attached to a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of septa subcutaneously, wherein the mechanical septa disrupting element is configurable to both define septa hooking structure as well as septa severing or disrupting structure. All cutting means can be combined with or further energized with RF, a laser, ultrasonic or thermal energy to produce cutting and coagulation together or separately. Moreover, the cutting means can include a blade that is one or more of highly sharpened, hardened or coated (for example titanium nitride or Teflon).

[0060] In certain aspects, there can be a single entry site or two entry sites on each side of the patient, one high on the hip and another along the crease or transition between the buttocks and thigh, or at the inner thigh. Such locations are characterized in that they can be easily hidden either naturally or by clothing. Treatment targets, depressions and dimples that have been marked on the skin surface while the patient is standing often go away when the patient lies down on their stomach because gravity acts on the skin and underlying connective tissue in a different direction such that the ink mark 204 is apparent, but the dimple or depression is not. The disclosed interventional devices are configured such that a user can approach a target location and first use the interventional device to push, pull or otherwise tension septa in a target area under the skin to identify the specific septa impacting the target and/or which is the cause of the appearance of cellulite. In other words, pulling or pushing is performed on the septa under the skin to find the one(s) that create the dimple or depression in the skin surface. Notably, enough force is employed in pulling or pushing septa to create a dimple or depression on skin and an assessment is made to determine if the created dimple or depression corresponds to targeted dimples or depressions that have been marked for treatment. If so, then the engaged septa are treated as described herein and this approach is repeated for all targeted treatment areas. The operator also confirms that all the septa associated with a targeted dimple or depression have been treated with the treatment device so that all of the septa associated with targeted dimples or depressions have been completely released.

[0061] With reference to Figs. 1E-G, it has been recognized that septa 350 define a complex network of connections between tissue layers 351 under the skin in and about the cellulite target areas, and septa includes “webs”, “trunks” and “branches from trunks” which connect tissue layers. It has also been recognized that septa can be quite elastic, stretching as much as about 10-20 mm before it creates depressions associated with the targeted area. In other circumstances, septa are inelastic and distances of about 10-25 mm are involved in creating enough tension for a dimple or depression to appear on the skin because of needed length of movement to tension long septa. Verification that all septa associated with a treatment target have been cut thus can involve multiple passes within a target area to ensure that an entire network of septa have been cut. Special attention is given to secondary septa that can be difficult to identify until after more readily identifiable or primary septa are cut. Secondary septa are septa that cause a shallower or smaller depression than the primary septa. Shallower or smaller depressions are not as noticeable on the skin when a patient is standing but after the primary septa to have been cut and there is no more deep depression, the shallower or smaller depression caused by the secondary septa becomes much more noticeable. Moreover, secondary septa and patterns of septa are expected and consequently searched in areas where there are multiple or closely located appearances of cellulite. In this way, a precise approach to relieving connective septa is taken in that septa hooked that create a depression outside the marked treatment area are released uncut and septa associated with targeted cellulite are cut. By taking multiple precision passes under a target area, all cellulite-forming septa, primary and secondary, are treated.

[0062] For some treatment targets, taking an approach from an entry located inferior the treatment target, advancing the end of the interventional device beyond the treatment target and then pulling inferiorly (effectively the “down” direction if the patient was standing) can provide a better approach, for example, for treatment targets on the leg, to re-create the dimple when the patient is lying down. One or more strain gauges can be incorporated within the treatment device to help identify target septa as well as to assess the progress and completion of treating septa. This facilitates targeting of key septa in a less impactful way, ideally minimizing bruising or other issues associated with cutting or disrupting a large area around the target. There are thus herein shown various approaches to treating cellulite expressed as dimples or depressions 200 in the skin surface. Moreover, the handle portion can be employed to create an indentation in skin through which interventional devices can be inserted subcutaneously. A treatment regimen is selected for inserting interventional instruments based upon the subject’s anatomy as it relates to the septa 350 connecting tissue layers that define the chambers retaining fatty or other tissues. If desired, while anesthetic and/or sedation is taking effect, ultrasound can be used to assess the subcutaneous trajectory and depth of the various connective tissue bands responsible for the surface unevenness. The ultrasound evaluation can help with the particular trajectory selected for the desired depth. The ultrasound evaluation can also help with positioning the distal end portion of the treatment instrument strategically at the connection point between the connective tissue and the dermis or the facia.

[0063] In another approach, there can be provided a depth calculation device 1200 configured to facilitate assessing the depth of a treatment device 225 within tissue (See Figs. 1H-I). The depth calculation device includes a light intensity sensor that is configured to measure the light output of a cellulite treatment device 225. The depth calculation device 1200 further includes a display 1201 that provides depth information to a user. Side buttons 1202 can be provided to navigate through the functionality provided by the display 1201, and red and green colors can be employed to quickly inform the user whether targeted depths are reached or maintained. The depth calculation device can further include a low light camera configured to measure light radius and can be positioned near the measurement sensor.

[0064] The depth calculation device 1200 is thus configured to detect the depth of light emitted by a treatment device to thereby provide information regarding the position of the treatment device 225 within tissue. In one approach, the treatment area is covered by the body of the depth calculation device 1200 so that only the light emanating from the treatment device through the skin can reach the light detector of the depth calculation device 1200. This is first performed at a beginning of a treatment procedure when the user knows that the treatment device 225 is in the correct tissue plane so that the depth calculation device 1200 can be calibrated as the intensity of light can differ based on varying skin properties. During the treatment procedure after calibration, the user can utilize the depth calculation device 1200 periodically to ensure that the treatment device 225 is still in a correct tissue plane. If the detected light intensity decreases by a certain percentage, the treatment device 225 is too deep and if the detected light intensity increases by a certain percentage, then the treatment device 225 is too shallow. The user can then adjust the treatment device 225 depth as necessary.

[0065] In another approach, the camera of the depth calculation device 1200 can be employed in conjunction with or independently of the light detector to assess the depth of the treatment device 225. When used together, the two approaches can be employed as comparison data points for assessing device depth. Here, a radius of a conical projection of light emitted through skin is measured using the camera and compared to a baseline value determined when it is known that the treatment device 225 is correctly positioned. The conical projections can be periodically checked throughout a treatment procedure. If the radius of light projection increases then the device is too deep and if the radius of light projection decreases then the device is too shallow, and adjustments to the depth of the treatment device 225 can be made.

[0066] As shown in Fig. 2A, targeted locations of cellulite to be treated can be marked 204 on the surface of the skin. This can be done when the patient is standing to best see cellulite. Cellulite can diminish or disappear when an individual is laying down, and should this happen, the marks 204 identify and confirm their locations (Fig. 2B).

[0067] In one aspect, local anesthetic is applied to the treatment site subcutaneously. In one approach, a long anesthesia needle (for example, 3.5 or 6 inches in length) is tunneled beyond a marked treatment site and anesthetic is administered under the marked area and along the tunneling pathway. It may be desirable to apply additional local anesthesia using a short needle transcutaneously to ensure that anesthetic extends beyond the marked target area. A distal end portion of a cellulite treatment assembly 220 is then inserted through the skin and the blunt tip is guided up into close proximity of the dermis as the tip can be tracked using the light source 352 at the distal end of the assembly as it is advanced toward septa 350 (Fig. 2C) near the marked location. Notably, the terminal end of the cellulite treatment assembly 220 in any of the disclosed embodiments can also define a tapered profile and include a tapered nosecone configured to assist in advancing the device between tissue layers. Entry sites are selected to both minimize post-operative healing time as well as to limit the use of anesthesia. The inventors have discovered given the goal of tensioning targeted septa 350, the distance from the marked location to where the treatment assembly 220 is inserted into the skin is preferably at least about 2 cm so that there is enough distance to pull and disrupt septa 350 and not have the tip of the cellulite treatment assembly exit the skin in the process. Additionally, a depth below the skin where septa 350 is preferably engaged (i.e., cut, sliced, torn, stretched, re-oriented (e.g. criss-crossing) or disrupted) is identified and determined. After determining the subcutaneous depth to be accessed for the cutting, slicing, tearing, stretching, re-orienting (e.g. criss-crossing) or disrupting of septum 350, the cellulite treatment assembly or other tool with a sharpened or blunt tip is inserted through the skin, advanced between subcutaneous tissue layers and toward septa 350. In one approach, a distal end portion of the cellulite treatment assembly is configured with a selectively activatable illuminated tip 352 that generates light (represented as illumination lines in the figures) with enough brightness to be seen through the skin. The intensity of light emitted by the tip 352 can be set to a specific constant level such that at the preferred depth below the skin for severing or otherwise engaging septa 350, the light that appears at the level of the skin as a circle or projection is of a pre-determined size. Thus, the treatment device is advanced to the target site. At the target site or as approaching the target site from the entry site, the user adjusts the depth of the tip of the treatment tool such that the circle or projection of light is the pre-determined size. Alternatively, to having an illuminated tip, an illumination element can be located proximal of the treatment device 225. In this embodiment, the projection of light can be positioned under or alongside the target site such that the circle or projection of light is at the pre-determined location and the treatment element will be known to be beyond the pre-determined location. The septa 350 is tested and if confirmed as a target for treatment, the septa 350 is treated while maintaining the circle or projection at the pre-determined size. The user can also use the size of the circle or projection of light to maintain the depth of the tip of the treatment tool as it is advanced under the skin to the treatment target. In an alternative or another aspect, a sharpened tip is employed to create access to target tissue thus allowing the tool to create the desired path both into tissue as well as between tissue layers. It is expected that the depth that these tools are advanced will be between about 3 and about 10 mm below the skin surface, but it is anticipated that lesser and greater depths may also be optimal for a particular subject. It has been recognized that a more superficial treatment depth can be particularly effective in cutting all septa associated with a treatment site, as well as secondary septa are cut and can be cut in early passes within a treatment site. Accordingly, in a relative superficial approach the treatment device is advanced at a depth closer to the dermis than the superficial fascia. In any event, the depth selected is chosen for cutting, slicing, disrupting, tearing, stretching or re-orienting of the subject’s septa 350. Moreover, in one embodiment, it is to be appreciated that the device 220 is formed from a substantially rigid material so that a consistent plane below the skin surface is accessed.

[0068] In another approach to precisely target and perform cellulite treatment procedures, a separate light source having a broad spread of light can be inserted into the target area through a separate incision or the same point that is less superficial to the skin layer. The treatment device is then advanced over this separate light source to identify where the treatment device is positioned through backlighting. By separating the light source from the treatment device, the treatment device can be less complicated, have fewer parts and constraints and can present a smaller profile requiring smaller incision sites and is easier to advance within tissue. Moreover, the treatment device would be subject to fewer electrical testing requirements and will potentially exhibit fewer electrical problems. In alternative or related approaches, a magnet can be incorporated into the treatment device and a magnet film can be placed over the skin to provide tracking of the treatment device. Also, a vein viewer-like apparatus can be employed to visualize reflectivity of a treatment device coated to demonstrate high reflectivity to identify device location, or near-IR light is employed to detect temperature differences between the treatment device and the patient’s skin to thus identify treatment device positioning.

[0069] Using palpation, direct visualization (for example, transillumination or endoscopic) or non-invasive visualization (for example, ultrasound or fluoroscopic) or other means for determining the position of the interventional tool such as markings along the length of the instruments and its path within tissue, or providing the interventional instrumentation with radiopaque markers, the tool is placed at a site below where cellulite (for example a dimple) is seen on the subject’s skin. The treatment device is advanced through septa 350 and to where the treatment device 225 is in a position best suited to accomplish the identification of target septa and the cellulite removal or minimization treatment. As shown in Figs. 2D-E, in one approach, the treatment device 225 is passed beyond septa 350 in a stored or collapsed configuration, and once positioned beyond septa 350, a hook is deployed. Next, the tool assembly 220 is then pulled proximally to tension septa 350, such as by hooking the septa (Fig. 2F). In another approach, the treatment device 225 is passed a few millimeters lateral, preferably about 1 to about 10 millimeters, more preferably about 3 to about 6 millimeters, and beyond the target location, a hook is deployed and then swept laterally toward the target followed by pulling proximally to hook and tension septa. In one aspect, during initial deployment, the hook structure defines a relatively flat angle, that is, an edge of the hook is at about 80 degrees relative to a long axis of the elongate member 224, which results in providing the treatment instrument with substantial reach. Once it is time to cut or otherwise engage septa 350, the treatment device 225 is manipulated so that its blade or other cutting surface is exposed at a more steep angle better for cutting, such as about 70 degrees relative to the long axis of the elongate member 224. During these and other steps, transillumination can be employed to track the treatment device and guide the procedure. The marks 204 can facilitate targeting of septa 350 while using transillumination to see the location of the treatment device 225. In other approaches, a separate device can be employed to engage septa 350 to see if such septa are the source of a dimple or depression expressed on the outside of the skin. Such a secondary device can be placed remotely from the target (i.e. lesion) and configured to be capable of applying tension to the surface of skin in a predetermined direction so as to create the effect of gravity and produce the visualization of the lesions while the patient is in a prone position (i.e. a broad region of adhesive attached to a spring mechanism such that a predetermined force would be applied relatively parallel to the surface of the skin in the direction the skin would move when standing in gravity). Using this additional device could further help the confirmation and location of lesions and allow confirmation that the treatment was effective. Also, in various approaches, a portion of the elongate member can be configured to transition from a smaller state to a wider or larger state, wherein in the wider or larger state a cutting surface (i.e. sharpened edge or energy) is presented to cut tissue, the device being sized and shaped to be inserted through the skin and engage one or more regions of septa subcutaneously.

[0070] It is noted that septa causing a dimple or depression may be coming from various angles and locations relative to the dimple or depression seen on the skin rather than being directly below the dimple or depression, and may be due to one or only a few septa or a large number of septa that remotely cause the depression or dimple. Thus, so engaging certain septa will be reflected in some change of the surface of the skin or in the dimple or depression on the skin. Because in most circumstances the dimple or depression disappears, a determination is made concerning the correspondence with marks 204 made on the skin and the dimples or depressions being formed or re-formed by the user utilizing the tool. If the initial septa 350 that the user presses on or pulls on using the tool do not recreate a dimple or depression in the marked area 204, then the user releases those initial septa that were engaged and repositions the tool at different septa and presses on or pulls again. This is repeated until the septa responsible for a dimple or depression in the marked location are identified (Fig. 2F). Once proper septa are identified, the tool 225 is manipulated to cut, slice, disrupt, re-orient, stretch or tear septum 350 connecting tissue layers. In one approach, a blade 353 is deployed and presented for treatment.

[0071] After the proper septa have been severed, disrupted, stretched, or reoriented, the treatment element 225 is moved back to its initial collapsed configuration. The treatment element is then advanced beyond the marked treatment location, the treatment element (e.g., hook) is deployed and then pulled back under the marked treatment location to confirm that all of the septa responsible for causing the marked dimple or depression have been separated intra-operatively. Again, multiple passes are taken to ensure that all cellulite-creating septa, including secondary septa are cut. If they have not been, the tool is manipulated to sever, disrupt, stretch, or re-orient additional septa. An approach is taken working right to left through an entire marked margin area and the steps are repeated until all of the septa responsible for creating the marked dimple or depression have been severed or sufficiently stretched and the dimple or depression cannot be re-created intra-operatively using the tool. Alternatively, or additionally, to check that the marked treatment targets have been adequately separated, treatment can be conducted with the patient lying down and the patient can then be asked to stand up off of the procedure table to let gravity act on the body to see whether marked treatment areas have been treated. Where the patient is asked to stand, steps are taken to maintain a sterile field and appropriate draping is provided to the patient. Where necessary, further treatment can be conducted on the unresolved areas. Such manipulation results in selective rupture, tearing, cutting or slicing of targeted septum 350, and the removal or minimization of dimples and the appearance of cellulite on skin (Fig. 2G). Thereafter, the treatment element (e.g., hook and/or blade) is retracted back in and the tool 220 is removed from the site to be withdrawn from the body or repositioned in any direction along and within the target tissue plane to treat additional areas.

[0072] With reference now to Figs. 3A-C, there is shown a treatment system that embodies certain functionality and a selected number of features described above. The treatment system includes a handle assembly 300 from which an elongate member 302 extends. The handle assembly 300 defines a contoured profile sized and shaped to conveniently fit within an operator’s hand. Various actuating members 304 are provided on the handle assembly 300 the manipulation of which accomplishes the deployment of a treatment device 310 employed to engage, test and/or cut septa. The elongate member 302 has a length and cross-sectional profile configured to be placed between tissue layers and to be advanced and extend to septa existing in a target treatment area. A distal end 312 of the treatment system (Fig. 3B) includes the treatment device 310 and a terminal end 314.

[0073] The distal end 312 portion (Fig. 3B) of the treatment system is also equipped with an exit port 320 for a light fiber 322 that provides the transillumination functionality described above. As shown in the cross-sectional view of the treatment system (Fig. 3C), the light fiber 322 extends distally from a light energy source and focusing assembly 330 configured within the handle assembly 300. The light fiber 322 extends distally through the handle and within the elongate member 302 to the exit port 320. A battery provides energy to an LED which generates light energy.

[0074] Various further alternative approaches to cellulite treatment systems can be employed. With reference again to Figs. 3B-C, the actuating members 304 are provided on the handle assembly 300 the manipulation of which accomplishes the deployment of a treatment device 310 employed to engage, test and/or cut septa. Thus, manipulating the actuating members 304 results in the treatment device 310 assuming home or sheath, open or hook and active or cut configurations. In use, the actuating members 304 are in a first proximal position and the treatment device 310 is in the home or sheath position . Next, the actuating members are advanced distally by pushing on the slider 306 so that the treatment device 310 assumes an open or hook configuration (Fig. 2E) and thereafter, an active button 307 of the actuating members is depressed so that the treatment device defines an active or cut configuration (Fig. 2F- G). To return to home, the home button 305 of the actuating members 304 is manipulated so that the treatment device 310 returns to the home or sheath configuration.

[0075] Turning to Figs. 4A-N, there are shown various views depicting among other things, the ornamental design of alternative approaches to a cellulite treatment assembly 220. The treatment assembly 220 includes a handle assembly 400 from which an elongate member 402 extends. Here also, the handle assembly 400 defines a contoured profile sized and shaped to conveniently fit within an operator’s hand. Moreover, an actuation assembly 404 is provided on the handle assembly 400 the manipulation of which accomplishes the deployment of a treatment device 410 employed to engage, test and/or cut septa. Again, the elongate member 402 has a length and cross-sectional profile configured to be placed between tissue layers and to be advanced and extend to septa existing in a target treatment area, and a distal end portion of the treatment system includes the treatment device 410. As with the previously described embodiment, the distal end portion of the treatment system can also be equipped with an opening for light from a battery powered light to be projected from to provide the transillumination functionality described above (See also Fig. 3C).

[0076] With reference to Figs. 4O-Q, there is shown a cross-sectional view of the handles depicted in Figs 4A-N. This approach to a handle assembly is configured to reduce the number of steps or actions required by a user to operate a treatment device. By doing so, potential for user fatigue is diminished and an amount of time required for a user to learn and internalize how to use the treatment device can be reduced. Handle assemblies can function by having three states, namely, home or sheathed, open or hook, and active or cut, where a user must take an action in order to place the device into a next state such as by pushing a button or moving a slider. In certain approaches described above, the user must take an action to return the actuating members to a home position. However, in the presently described embodiment, the user action associated with returning the actuating members to the home state can be eliminated. In a specific approach, the return of the actuating members to the home position can be made despite tension provided by tissue against the treatment device. This may be necessary when a user has completed a cut, and a blade of the treatment device comes to rest against nearby tissue structures with some amount of tension that can interfere with the mechanism returning to the home position. Eliminating the manual action to return to home also reduces the number of buttons or sliders presented to the user and as stated, facilitates more quickly learning how to use the treatment device. Further, the disclosed handle assembly prohibits an actuating mechanism to return to the home position until a tissue cutting actuating mechanism is released. This can prevent confusion as to which state the device currently assumes.

[0077] As shown in Figs. 4O-Q, the handle assembly 400 includes a body supporting an actuating assembly 404. The actuating assembly includes a slider 450 biased by a spring 452, and a cut button 454 also optionally biased by a spring 455. The slider 450 and cut button 454 are configured to manipulate a pushrod 456 including a pushrod block 457, that is also biased by a spring 458. The pushrod 456 is operatively associated with a treatment device (not shown). The pushrod 456 is not permanently connected to either the slider 450 or the cut button 454, but is handed off between the two structures. Once the cut button 454 is released, the pushrod 456 is freed from the slider 450 and cut button 454, thereby allowing a full potential energy of its spring 458 to work against any device residual tip tension without being hampered by friction imposed by the mechanical action of handle components. In this way, performance against tissue tension at a distal tip of the treatment device can be optimized. Action of the pushrod 456 is controlled by a latch 460 that is loaded by a spring 462. The latch 460 includes a first projection 466 that rides in a first track 468 formed in the slider 450 and a second triangular shaped track 470 formed in the cut button 454, and a second projection 472 that rides in a third track 474 formed in the cut button 454.

[0078] Also configured within the handle assembly 400 is a damper assembly 480.

The damper assembly 480 includes a damper arm 482 and one or more dampers 484. Although the component parts of the damper assembly can assume various constructions, as shown, the damper arm 482 includes diverging projections 485 and is configured to be pivotable within the handle 400 relative to the damper 484. The damper 484 includes a disc-like portion 486 that functions like a brake as it engages structure of the damper arm 482. The damper assembly 480 is operatively associated with the slider 450 to control the return of the handle 400 to a home state. The damper assembly 480 slows the return of the slider 450 to a proximal position to provide a slow close feature or functionality. The damper assembly 400 also reduces noise and vibration associated with the return of the slider 450 to a home position. In this way, a treatment procedure involving this damper feature is more controlled and facilitates avoiding startling a patient with noises emanating from the treatment device during a procedure.

[0079] In a home state (Fig. 40) where the treatment device is in a stowed position, the slider 450 is in a proximal position and the cut button 454 is undepressed. As the slider 450 is pushed forward, the first projection 466 travels within the second track 470 and locks the device in an open state (Fig. 4P). The slider 450 is advanced distally against the force provided by springs 452 and 458. Such action causes the slider 450 to engage a damper arm projection 485 and to rotate the damper arm 482 through its engagement with the damper 484. In this way, the slider 450 is provided with a smooth transition to its distally locked position. This advancement of the slider 450 also causes the pushrod 456 to be advanced against the spring 458 associated therewith. The translational force asserted by the user against the slider is preferably between 0 and 4 pounds, to reduce fatigue and provide a comfortable experience.

[0080] At this point, the treatment device is deployed to present a hook configuration but a blade or cutter of the treatment device is covered or undeployed. Next, when the cut button 454 is depressed (Fig. 4Q), the first projection 466 unlatches from the first track 468 but the treatment device is held in the open state by the second projection 472 configured in the third track 474 formed in the cut button 454 as well as the cut button 454 against the pushrod block 457. Now, the treatment device is in a cutting configuration where the blade or cutter of the treatment device is exposed and can be used to treat target tissue.

[0081] Upon releasing the cut button 454, the second projection 472 unlatches, allowing the slider 450 to return to its proximal position and the cut button 454 to return to its undepressed configuration. The return of the slider 450 to its home position is facilitated by the energy provided by the spring 452 associated with the slider 450. The damper assembly 480 slows and quiets the return action of the slider 450 through the engagement of the damper arm 482 with the damper 484. Such control is provided when the slider 450 engages another projection 485 to rotate the damper arm 482 through its engagement with the damper 484, and frictional force slows the action of the slider 450. The treatment device thus automatically returns to the stowed configuration and the handle assembly 400 is in the home state (Fig. 40).

[0082] The treatment device 310 can assume various configurations embodied in one or more embodiments of a mechanical connective tissue disrupting element. With reference to Figs. 5A-C, there is shown an alternative approach to a treatment device 310 that includes a blade 502 housed within a tube 504. The blade 502 is operatively associated with a pushrod 506 that is configured to be translated longitudinally within the tube 504. At a distal end portion of the pushrod 506 there is configured a cam structure 508 that interacts with cooperating cam structure 510 embodied on a base of the blade 502. The pushrod 506 is controlled by structure (not shown) configured within a handle assembly 300, 400 such as that shown above. The pushrod 506 is not fixedly connected to the blade 502 but rather operates via the cam action between the cooperating features on the pushrod 506 and blade 502 to thereby present the blade 502 in a simple pivoting action.

[0083] In a distal position (Fig. 5A), the pushrod 506 forces the blade 502 into a sheathed position. The cam structures 508, 510 are configured to prevent any blade 502 motion and the blade is retained within an outer perimeter of the tube 504. Withdrawing the pushrod 506 to a proximal position (Fig. 5B) forces a tip of the blade 506 to a position outside a perimeter of the tube 504 thus placing it in a position to swing freely outward. As the treatment assembly is withdrawn proximally through tissue, the blade 502 catches or engages septa or other subcutaneous structures which causes the blade 502 to swing out and be held to a full deployment position (Fig. 5C) provided by engagement between a distal end of the pushrod 506 and the base of the blade 502.

[0084] In its full deployment position, the treatment device 310 including blade 502 is manipulated as desired or directed to engage tissue at a target treatment site. During treatment, the pushrod 506 is advanced distally to stow the blade 502 as is needed for re-positioning, or at an end of the treatment, to withdraw the treatment device at the completion of a treatment. Thus, this approach provides a ready or sheathed treatment assembly having two functional treatment positions and which embodies a relatively simple to manufacture device.

[0085] In an alternative approach (Fig. 5D), the treatment device 310 can be provided with two spaced blades 506 that are deployable from opposite sides of the tube 504. The deployment and sheathing of the two blades 506 could be synchronized with a single pushrod or independently controlled by two pushrods (not shown).

[0086] One approach to a disengageable scissor arrangement 600 for a treatment device 310 embodying a mechanical connective tissue disrupting element is shown in Figs. 6A-C. The scissor arrangement 600 is configured at a distal end portion of treatment system shaft 601 and provides increased precision and alleviates fatigue due to repeated application of high force maneuvers. In this approach, a home position (Fig. 6A) of the scissor arrangement 600 is completely open, that is the pivoting member 602 including a cutting edge or bevel 603 is nearly 180 degrees to the opposite cutting surface 604 and forms the terminal end of the treatment device 310. In this regard, the pivoting member 602 includes or defines a blunted end featured to be atraumatic while driving the device to a target area within tissue. Half or partially closing pivoting member 602 converts the arrangement 600 to an open position (Fig. 6B) and the operator can return the pivoting member to the home position (Fig. 6A) if disengaging is desired or the operator can move the pivoting member 602 to the cut position (Fig. 6C) to complete the cutting action. In this approach, the pivoting member 602 is rotatably connected at a joint to an L-shaped strut 608, which in turn is operatively connected to a pushrod 610 housed within the shaft 601. Advancing and withdrawing the pushrod 610 results in the pivoting member 602 assuming home, open and cut configurations or positions.

[0087] With reference to Figs. 7A-B, a treatment assembly 620 embodying a mechanical connective tissue disrupting element can additionally or alternatively include a deployable basket 622 in addition to a treatment device 624 configured for engaging and/or cutting septa. Separately from liposuction, area smoothing or fat redistribution can be provided without the removal of fat. Here, the clinician can use a basket 622 and move it through a target area to disrupt and/or equalize fat in the area. In one approach, the basket 622 is formed by a slotted tube made from metal or plastic that when compressed, the relieved sections expand to create an expanded basket. In one aspect, a diameter of the expanded basket 622 can be adjusted based on an amount of compression applied based on a user preference.

[0088] Turning to Figs. 8A-C, there is shown a treatment device 310 embodying a mechanical connective tissue disrupting element that embodies a self-cleaning electroblade assembly 670 configured to reduce forces required to sever septa. In this approach, the device 310 includes a bipolar electrode with a small fixed gap between poles across which current is passed to ablate tissue in contact with both poles. Thus, an electro-blade assembly 670 is created by translating both poles of a bipolar circuit over a fixed gap with target tissue completing the circuit. Such a fixed gap allows for a consistent delivery of energy set by the gap width which reduces user complexity.

[0089] As shown in Fig. 8A, the electroblade assembly 670 includes spaced and rotatable blades 672 configured on opposite sides of a fixed insulator 673. The outer elongate tube or shaft 674 of the treatment device 310 to which the blades 672 and insulator 673 are attached or supported is shown as transparent. The blades rotate about a pin 675. A wire or wires 676 extends longitudinally to the blades 672 from a proximal end of the device 310 to thereby provide the necessary electrical energy to the electroblade assembly 670. Further, a push rod 678 extends longitudinally within the shaft 674 and is operatively associated with the blades 672. Manipulation of the push rod 678 functions to rotate the blades 672.

[0090] As shown in Figs. 8B-C, longitudinally extending or withdrawing the push rod 678 causes the two blades 672 to rotate about the insulator 673 which isolates them from each other when not in use. When tissue is ready to be cut, the blades 672 are rotated beyond the insulator 673 by the push rod 678 (Fig. 8B), and the blades 672 are then exposed to the target tissue (not shown). The target tissue is then tensioned across the blades 672 and current is passed between the blades 672 to thereby ablate the tensioned tissue.

[0091] When the target tissue is cut, the blades 672 are rotated back and passed the insulator 673 by employing the push rod 678 (Fig. 8C). Any tissue remnants that may be attached to the blades 672 is cleared from the blades 672 as they move along the insulator 673. The blades 672 can then be returned to a shielded or neutral position (Fig. 8A) by the push rod 678 for traversal within tissue. In one alternative approach, the blades 672 can be spring loaded to return to a shielded position (Fig. 8A). In another alternate approach, the blades can be configured to linearly translate between neutral, cutting and cleaning positions.

[0092] With reference to Figs. 9A-H, there are various embodiments of a treatment device 310 embodying a mechanical connective tissue disrupting element that embody a scissor-tube cutting mechanism 690. A scissor-tube cutting mechanism utilizes an edge of an opening in a tube as one of the members of a scissor like mechanism in which an edge of one member moves along the edge of another member to cut material. This approach requires reduced levels of force needed to cut target tissue and provides a more precise cut. Also, employing one deployable member and one fixed surface for cutting, a smaller profile device can be provided, and moving a single member simplifies the mechanism utilized for actuation as compared to two moving parts.

[0093] In Figs. 9A-D, a pivoting member including a cutting edge or a bevel 692 is utilized as a first element facilitating cutting, where a second cutting surface 697 is located in the window 696 of an outer tube 694. As seen in Figs. 9D and 9F, the pivoting member 692 is curved along its length toward the second cutting surface 697 in window 696. By having a curve along the pivoting member 692, a pre-load and a pivoting member load can be created and maintained which lends itself to achieving an effective cut (See Figs. 9C-D). In another approach (Figs. 9E-F), the cutting surface 697 is curved as well to create a crossover between the pivoting member 692 and tube edge 697. The tube edge can be changed or adapted to define an interfacing edge that presents or allows for optimum blade or pivoting member load through the cut. In another embodiment, the pivoting member is straight along its length and the cutting surface 697 in window 696 is curved along its length so load is created and maintained as the pivoting member is closed into the window during cutting.

[0094] As shown in Figs. 9A-B, a push rod 698 extends longitudinally within the outer tube 694. Pivotably attached to a terminal end of the push rod 698 is an arm 700, a distal end of which is pivotably attached to the pivoting member 692. The pivoting member 692 is in turn connected to a fixed pivot 701 configured within the outer tube 694. Manipulating the push rod 698 thus causes the pivoting member 692 to rotate between a deployed configuration (Fig. 9A) and a stowed position (Fig. 9B).

[0095] In another embodiment, as best seen in Fig. 9G, the window 696 includes a cut surface 702 against which the hook 693 engages to complete a cut of tissue. The hook 693 itself includes a blunted surface or a flat 704 (FIG. 9H) so that tensioning septa to re-create a cellulite depression is possible without cutting tissue when the hook is in a deployed position (Fig. 9A). Actuating or rotating the hook 693 into the outer tube 694 along cutting surface 702 then accomplishes the cutting of targeted tissue. After targeted tissue is cut, the hook 693 can be returned to a stowed position (Fig. 9B) to position the device at another interventional site.

[0096] In an alternative embodiment (FIG. 91), the pivoting member 692 includes a relief feature 703. The relief feature 703 resides between the outer tube 694 and the angle it defines with the pivoting member 692, and increases the angle of incidence between the pivoting member 692 and the outer tube 694. This feature facilitates presenting a less acute angle than what is required to start cutting targeted tissue so that tissue can be tensioned without being cut. When the pivoting member 692 is opened or deployed, the relief feature 703 opens the incidence angle from acute to obtuse. In this way, tension can be applied to target tissue without cutting the tissue. When the pivoting member 692 is actuated to cut tissue, the relief feature 703 is retracted into the outer tube body 694 and the incidence angle changes to acute, thereby enabling cutting. In yet another embodiment, blocker or shield structure such as conformal material (e.g., plastic, silicone, etc.) could be employed in place of or addition to the relief feature to provide desired angles of incidence or to otherwise interfere with tissue ingress into the cutting area between blades.

[0097] Turning now to Figs. 10A-D, there is shown another embodiment of a treatment system 760 including a handle assembly 762 and a shaft 764 extending longitudinally therefrom. Configured at a distal end of the shaft 764 is a treatment device 766 embodying a mechanical connective tissue disrupting element. The handle assembly 762 includes a rocker assembly 768 that rotates about a pivot 769 and employs rotary motion to cause a pushrod 770 to translate linearly. Such action accomplishes placing the treatment device 766 into home, open and active configurations. Such linear translation can be defined by an angular travel on the rocker assembly 768 that can be defined by hard stops on the handle or via latches or other securement mechanisms. Further, this structure enables a user to maintain their hand in the same position while transitioning the treatment device 766 between home, open and active configurations, while providing the user with significant leverage so that hand forces can remain relatively low.

[0098] In one approach, the pivot 769 is defined by a pin extending laterally from the pushrod 770. The rocker assembly 768 includes a generally open V-shaped actuator 772 sized and shaped to accept a finger or a portion of a user’s hand. Notably, the overall size of the actuator can be adjusted to provide a desired advantageous moment action, and consequent movement of the pushrod 770. The actuator 772 extends from a shaft 774 that has a slot 776 formed therein. The slot 776 is configured to receive the pivot 769 associated with the pushrod 770. Rocking the actuator 772 forwardly causes the treatment device 766 to assume a home position (Figs. 17A-B). Rocking the actuator 772 backwardly results in the treatment device 766 to assume a deployed position (Figs. 10C-D). In this way, targeted tissue can be effectively cut using less effort.

[0099] Turning to Figs. 11 A-B, there is shown a treatment assembly 800 that includes a lumen 802 and a deployable treatment device 804 embodying a mechanical connective tissue disrupting element. The lumen 802 extends from a proximal end of the treatment assembly 800 to its terminal end. The lumen 802 is configured for anesthetic delivery, fat removal, or fat/filler delivery. Such an assembly 800 provides procedural efficiency in that an operator need not switch between different devices but can use one device to target septa with the treatment device 804, and also administer anesthesia and/or deliver or remove fat or fillers through an exit port 806. The terminal end of the assembly 800 can be machined, molded or cast. In one approach, the lumen 802 is maximized while maintaining the function and performance of the deployable treatment device 804. In various approaches, the treatment device 804 can be sealed off from the lumen 802 to maintain functionality.

[00100] As shown in Figs. 12 A-B, a treatment assembly 810 can have a relatively longer shaft 812 to limit a number of entries required to complete a treatment. The diameter of the shaft 812 can also be slightly larger to provide desired stiffness, such as by adding an overtube to the assembly. Further, the shaft 812 can be curved or curvable to reach and treat targeted body structures. In this regard, a pushrod functioning to actuate a treatment device 814 configured at an end of the treatment assembly 810 can be constructed to provide linear translation within a curved shape. In one embodiment, the pushrod 816 can include cut-out slots 818 that allow bending in one plane while still allowing the pushrod 816 to have an ability to actuate the treatment device 814.

[00101] After completing treatment of one target area employing one or more of the disclosed treatment devices, the procedures described herein can repeated to treat other target areas. Accordingly, the same devices can be employed to access tissue layers below other sites or depressions existing in skin. Notably, in one embodiment, the devices are capable of anesthetic delivery as needed or desired when progressing to additional or new locations. There is thus provided a system configured to treat all target areas on the body through a limited number of small entry sites, including through a single entry site on each side of the patient. It is to be recognized that the system can further include structure permitting the assembly to be steerable to subcutaneous treatment sites. In such an embodiment, the device would be configured to define longitudinally flexible material, and the instrumentation would be steered to the desired position within tissue. Moreover, in certain applications, the device has a stiffness that varies along its length. In another embodiment, the treatment and fat collection devices are embodied in deflectable catheters.

[00102] In each of the disclosed approaches and apparatus, should engagement of such septa result in some change in the dimple or depression expressed on the skin, the treatment structures are manipulated to disrupt, cut or slice the tissue. Thus, the treatment structures are opened and tissue is placed between its cutting structure. Next, the cutting structures are advanced against or caused to be closed about the tissue to thereby cut, slice or sever the tissue, thus relieving the tension between tissue layers and eliminating or minimizing the appearance of the unwanted feature on the skin. Actuation is accomplished from a proximal end of the treatment device such as by pulling a wire or advancing and pushing an elongate member associated with the scissor arrangement. Illumination can be provided by a light configured proximal of the treatment or fat collection devices so that transillumination can be employed to track the location of the distal portion of the treatment assembly. Additionally, or alternatively, in each disclosed embodiment, illumination can be via a lightguide from an external light source or via one or more LEDs. Illumination aids the user both with locating the treatment device as well as proper depth placement as transillumination decreases with increasing tool depth. In one aspect, the amount of illumination is set to ensure proper depth of a treatment device or structure, the level of illumination targeted being adjusted for skin type, thickness, presence of fat and pigment.

[00103] In employing one or more of the disclosed embodiments in a treatment procedure, there is an expectation that there are instances where it is preferable to not disrupt a hooked tissue, and in such a case it is desirable to release or disengage the hooked tissue. In certain approaches, to release or disengage, the treatment device would be advanced or twisted away from the hooked tissue. Accordingly, various approaches to aesthetic treatment methods and apparatus are presented. The disclosed approaches are configured to provide an effective and focused approach to treating, minimizing and preventing unwanted skin features. The disclosed approaches can also be used to repair and reduce the appearance of unwanted features in a targeted manner. Further, the disclosed proactive treatment modalities are easy and effective to use.

[00104] Some of the specific aspects of the present disclosure include one or more of focal treatment of just the tissue responsible for causing unwanted features in the skin; minimizing bruising; accessing all treatment targets from limited, cosmetically acceptable entries; capture and retention of tissue while separating the tissue; intra-operative confirmation of the treated target; needle-diameter sized tools for small openings; and transillumination identification of tool tip location.

[00105] While the present disclosure has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the present disclosure.

Claims

CLAIMS: That which is claimed is:

1. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; wherein the handle includes a body and an actuating assembly configured to control operation of the mechanical connective tissue disrupting element, the actuating assembly including actuating structure that places the mechanical connective tissue disrupting element into connective tissue severing or disrupting structure and facilitates an automatic return of the mechanical connective tissue disrupting element to a home position.

2. The aesthetic treatment system of claim 1, wherein the actuating assembly includes a slider and a cut button.

3. The aesthetic treatment system of claim 2, wherein the slider is configured so that advancement thereof relative to the body of the handle places the mechanical connective tissue disrupting element into an open state to present a hook configuration.

4. The aesthetic treatment system of claim 3, the handle further comprising a damper assembly that is configured to one or more reduce noise or speed associated with the handle returning to a home configuration.

5. The aesthetic treatment system of claim 4, wherein the damper assembly includes a damper configured to engage a damper arm, the damper arm being responsive to movement of the slider.

6. The aesthetic treatment system of claim 1, wherein the handle defines a contoured profile sized and shaped to conveniently fit within an operator’s hand.

7. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; wherein the mechanical connective tissue disrupting element includes one or more blades that assume a stowed configuration and deployed locked configurations.

8. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element a ta distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; wherein the mechanical connective tissue disrupting element defines a disengageable scissor configuration.

9. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; wherein the mechanical connective tissue disrupting element includes a pair of spaced blades.

10. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; and at least one electrode attached to the elongate member and configured to apply energy to target tissue.

11. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; and wherein the mechanical connective tissue disrupting element includes a self-cleaning electrode assembly.

12. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; and wherein the mechanical connective tissue disrupting element includes a scissor-tube cutting mechanism.

13. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; and a handle assembly including a rocker assembly configured to actuate the mechanical connective tissue disrupting element.

14. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member; and a depth calculation device including a light intensity sensor and a camera configured to assess a radius of conical projection of light.

15. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: a point of use IV bag scale configured with a display configured to display mass or volume of anesthesia administered during a treatment procedure, the display providing regional delivery of anesthesia information and total volume delivery of anesthesia information.

16. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; and a deployable basket configured to disrupt fat.

17. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; and a lumen extending from a proximal end to a terminal end of the treatment assembly, the lumen configured for one or more of anesthetic delivery, fat removal or fat delivery.

18. An aesthetic treatment system for treating appearances of a patient’s skin associated with a treatment site, comprising: an aesthetic treatment assembly including an elongate member extending from a handle and configured to be insertable through the skin and a mechanical connective tissue disrupting element at a distal end of the elongate member that is capable of expanding at least one region from a smaller state to a wider state and engaging one or more regions of connective tissue subcutaneously, wherein the mechanical connective tissue disrupting element is configurable to both define connective tissue hooking structure as well as connective tissue severing or disrupting structure; and wherein the elongate member is curvable.